Global Point Of Care Infectious Disease Testing Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In January 2023, Cipla Inc. launched Cippoint, a CE IVD,approved point,of,care testing device designed to diagnose non,communicable and infectious diseases.

• In February 2022, Trinity Biotech received World Health Organization (WHO) approval for its TrinScreen HIV, a rapid HIV screening test that provides results in under 12 minutes from a fingerstick blood sample.

Segment analysis of the Global Point-of-Care Infectious Disease Testing Market provides valuable insights into the factors driving market growth and shaping its landscape. This analysis typically encompasses several key segments, including product type, technology, application, end-user, and region.

Product type segmentation distinguishes between different categories of point-of-care infectious disease testing devices, such as molecular assays, immunoassays, and rapid antigen tests. Molecular assays, including nucleic acid amplification tests (NAATs) and polymerase chain reaction (PCR) assays, are highly sensitive and specific, capable of detecting viral, bacterial, and parasitic infections at the molecular level. Immunoassays, on the other hand, detect infectious agents by measuring specific antibodies or antigens in patient samples, offering rapid results without the need for complex laboratory equipment. Rapid antigen tests provide quick and convenient detection of viral antigens, making them ideal for point-of-care testing in various healthcare settings.

Technology segmentation delves into the different diagnostic technologies employed in point-of-care infectious disease testing. This includes molecular diagnostics, immunoassays, and lateral flow assays, among others. Advances in technology have led to the development of rapid and portable testing devices that offer high sensitivity, specificity, and ease of use, thereby expanding access to infectious disease testing in diverse clinical settings.

Application segmentation focuses on the clinical applications of point-of-care infectious disease testing, including screening, diagnosis, monitoring, and surveillance. These tests are used for detecting a wide range of infectious agents, including viruses, bacteria, fungi, and parasites, across various medical specialties such as primary care, emergency medicine, infectious diseases, and obstetrics/gynecology.

End-user segmentation delineates the different healthcare facilities and settings where point-of-care infectious disease testing is performed, including hospitals, clinics, ambulatory care centers, and community health centers. Point-of-care testing enables rapid diagnosis and treatment initiation at the patient's bedside or in non-traditional healthcare settings, improving patient outcomes and reducing the burden on centralized laboratory facilities.

Region-wise segmentation highlights the geographical distribution of the Global Point-of-Care Infectious Disease Testing Market, providing insights into regional market dynamics, trends, and growth opportunities. This segmentation enables stakeholders to identify key markets, target specific regions for expansion, and tailor their strategies to local market needs and preferences.

Segment analysis of the Global Point-of-Care Infectious Disease Testing Market offers a comprehensive understanding of the market landscape, helping stakeholders make informed decisions and capitalize on emerging opportunities for growth and innovation.

Global Point Of Care Infectious Disease Testing Segment Analysis

In this report, the Global Point Of Care Infectious Disease Testing Market has been segmented by Disease, End-Use and Geography.

Global Point Of Care Infectious Disease Testing Market, Segmentation by Disease

The Global Point Of Care Infectious Disease Testing Market has been segmented by Disease into HIV POC, Clostridium difficile POC, HBV POC, Pneumonia or Streptococcus associated infections, and Respiratory syncytial virus (RSV) POC.

The segmentation of the Global Point-of-Care Infectious Disease Testing Market by disease category provides insights into the specific infectious diseases targeted by point-of-care testing solutions. This segmentation helps healthcare providers and stakeholders understand the breadth and depth of diagnostic testing capabilities available for different infectious diseases, enabling tailored approaches to disease management and control.

One key segment within the market is HIV Point-of-Care (POC) testing, which addresses the global burden of HIV/AIDS by providing rapid and accessible diagnostic solutions for HIV infection. HIV POC testing allows for early detection of HIV antibodies or viral antigens in patient samples, enabling timely diagnosis, linkage to care, and initiation of antiretroviral therapy. Point-of-care HIV testing is particularly valuable in resource-limited settings, where access to centralized laboratory facilities may be limited, and timely diagnosis is critical for improving patient outcomes and reducing transmission.

Another significant segment is Clostridium difficile Point-of-Care (POC) testing, which addresses the growing challenge of Clostridium difficile infection (CDI) in healthcare settings. CDI is a leading cause of healthcare-associated infections, characterized by severe diarrhea and potentially life-threatening complications. Point-of-care testing for C. difficile toxins allows for rapid detection of the bacterium in patient samples, facilitating prompt diagnosis, infection control measures, and appropriate antibiotic management to reduce the spread of infection and improve patient outcomes.

HBV Point-of-Care (POC) testing represents another important segment within the market, focusing on the detection of hepatitis B virus (HBV) infection. HBV is a major global health concern, with millions of people affected by chronic HBV infection and its associated complications, including liver cirrhosis and hepatocellular carcinoma. Point-of-care testing for HBV markers, such as HBsAg and anti-HBV antibodies, enables rapid diagnosis, monitoring of disease progression, and evaluation of treatment response, contributing to improved patient management and public health outcomes.

Global Point Of Care Infectious Disease Testing Market, Segmentation by End-Use

The Global Point Of Care Infectious Disease Testing Market has been segmented by End-Use into Hospitals, Clinics, Home, Assisted Living Healthcare Facilities, Laboratories and Others.

The segmentation of the Global Point-of-Care Infectious Disease Testing Market by end-use provides insights into the diverse settings and facilities where point-of-care testing is utilized to diagnose and manage infectious diseases. This segmentation reflects the breadth of applications and settings in which point-of-care testing plays a crucial role in improving healthcare access, patient outcomes, and public health outcomes.

Hospitals constitute a significant segment within the market, representing large healthcare facilities that provide comprehensive medical services, including diagnostic testing, treatment, and care for patients with infectious diseases. Point-of-care infectious disease testing in hospitals enables rapid diagnosis, treatment initiation, and infection control measures, particularly in emergency departments, intensive care units, and other high-acuity settings where timely interventions are critical.

Home-based testing represents an emerging segment within the market, driven by technological advancements and consumer demand for convenient and accessible diagnostic solutions. Point-of-care infectious disease testing kits designed for home use allow individuals to perform self-testing for various infectious diseases, including sexually transmitted infections, respiratory infections, and chronic viral infections such as HIV and hepatitis C. Home-based testing kits empower individuals to take control of their health, monitor disease status, and seek timely medical intervention when necessary.

Assisted living healthcare facilities, including nursing homes, long-term care facilities, and residential care homes, represent another segment of the Point-of-Care Infectious Disease Testing Market. These facilities cater to elderly or chronically ill individuals who may be at increased risk of infectious diseases and complications. Point-of-care testing in assisted living facilities enables early detection of infectious diseases, facilitates infection control measures, and supports timely medical interventions to prevent outbreaks and protect vulnerable populations.

Laboratories serve as a critical segment of the Point-of-Care Infectious Disease Testing Market, providing centralized testing services, quality control, and technical expertise to support point-of-care testing programs. While point-of-care testing is performed at the patient's bedside or in decentralized settings, laboratory support is essential for test validation, quality assurance, result interpretation, and data management. Laboratories also play a key role in confirming point-of-care test results, conducting additional testing when necessary, and supporting epidemiological surveillance efforts.

The "Others" category encompasses additional end-use settings where point-of-care infectious disease testing may be utilized, including mobile healthcare units, research laboratories, and public health agencies. These settings may have unique requirements and preferences for point-of-care testing solutions, depending on their specific clinical focus, patient population, and operational needs.

Global Point Of Care Infectious Disease Testing Market, Segmentation by Geography

In this report, the Global Point Of Care Infectious Disease Testing Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Point Of Care Infectious Disease Testing Market Share (%), by Geographical Region, 2024

The Global Point-of-Care Infectious Disease Testing Market exhibits diverse regional dynamics, with variations in market share across different geographical regions. Understanding these regional nuances is crucial for stakeholders to effectively target markets, allocate resources, and capitalize on growth opportunities.

North America typically commands a significant share of the Global Point-of-Care Infectious Disease Testing Market. This region's dominance is attributed to several factors, including advanced healthcare infrastructure, high healthcare expenditure, and robust investment in medical innovation. The United States, in particular, leads the North American market, driven by its large healthcare sector, strong regulatory framework, and high adoption rates of point-of-care testing technologies.

Europe represents another substantial market share in the Global Point-of-Care Infectious Disease Testing Market. Countries within the European Union, including Germany, the United Kingdom, and France, are key contributors to market growth, supported by well-established healthcare systems, favorable reimbursement policies, and increasing demand for rapid diagnostic solutions. Additionally, ongoing technological advancements and the integration of digital health initiatives further bolster market expansion in the region.

The Asia-Pacific region is experiencing rapid growth in the Point-of-Care Infectious Disease Testing Market, fueled by factors such as increasing healthcare expenditure, expanding patient populations, and rising demand for accessible diagnostic solutions. Countries like China, Japan, and India are driving market growth in the Asia-Pacific region, propelled by government initiatives to improve healthcare infrastructure, enhance diagnostic capabilities, and address unmet medical needs. Moreover, the growing prevalence of infectious diseases and the adoption of point-of-care testing technologies in remote and rural healthcare settings contribute to market expansion in the region.

Latin America, the Middle East, and Africa collectively account for a smaller but growing share of the Global Point-of-Care Infectious Disease Testing Market. These regions are characterized by evolving healthcare systems, expanding healthcare access, and increasing awareness of the importance of rapid diagnostic testing in disease management. Market growth in Latin America, the Middle East, and Africa is supported by investments in healthcare infrastructure, partnerships with international healthcare providers, and initiatives to improve healthcare quality and accessibility.

The geographical distribution of the Global Point-of-Care Infectious Disease Testing Market reflects regional variations in healthcare needs, infrastructure, and market dynamics. Understanding these regional nuances enables stakeholders to tailor their strategies, products, and services to meet the specific needs and preferences of different markets, driving sustainable growth and maximizing market potential.

This report provides an in depth analysis of various factors that impact the dynamics of Global Point Of Care Infectious Disease Testing Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Increasing Prevalence of Infectious Diseases Globally
• Technological Advancements in Point-of-Care Testing Devices
• Growing Demand for Rapid Diagnostic Solutions

• Decentralization of Healthcare Delivery Models - The decentralization of healthcare delivery models emerges as a significant driver propelling the growth of the Global Point-of-Care Infectious Disease Testing Market. Traditional healthcare delivery models often rely on centralized laboratory facilities for diagnostic testing, leading to delays in results and challenges in accessing timely care, particularly in remote or underserved areas. Point-of-care infectious disease testing addresses these limitations by bringing diagnostic testing closer to the patient's point of care, enabling rapid diagnosis and treatment initiation.

  Decentralization of healthcare delivery models entails the expansion of diagnostic testing capabilities beyond traditional laboratory settings to various healthcare facilities and non-traditional settings, including hospitals, clinics, ambulatory care centers, pharmacies, and community outreach programs. Point-of-care testing allows healthcare providers to perform diagnostic tests at the bedside, in outpatient settings, or even in the field, facilitating immediate decision-making and patient management. This decentralized approach to diagnostic testing improves healthcare access, reduces turnaround times for results, and enhances patient outcomes, particularly in resource-limited or remote environments where access to centralized laboratory facilities may be limited.

  The decentralization of healthcare delivery models aligns with the broader trend towards patient-centered care and personalized medicine. Point-of-care infectious disease testing empowers patients by providing rapid access to diagnostic information, enabling them to participate in shared decision-making and take proactive measures to manage their health. Patients benefit from shorter wait times, reduced travel burdens, and increased convenience associated with point-of-care testing, leading to greater satisfaction and engagement in their healthcare journey.

Restraints

• Regulatory Challenges and Compliance Requirements
• Limited Sensitivity and Specificity of Point-of-Care Tests
• Concerns Regarding Accuracy and Reliability of Results

• Cost Constraints and Reimbursement Issues - Cost constraints and reimbursement issues pose notable restraints to the widespread adoption and sustainability of Point-of-Care Infectious Disease Testing. While these testing solutions offer rapid results and improved access to diagnostics, they often come with higher upfront costs compared to traditional laboratory-based testing methods. Point-of-care testing devices and assays may require significant investments in equipment, consumables, and training, particularly for smaller healthcare providers with limited budgets and resources. Additionally, ongoing operational expenses, including maintenance, quality control, and personnel training, can further strain financial resources.

  Reimbursement for point-of-care infectious disease testing varies widely across different healthcare systems and payers, leading to uncertainty and challenges for healthcare providers seeking adequate reimbursement for testing services. Reimbursement rates may not fully cover the costs associated with point-of-care testing, resulting in financial losses for healthcare providers or limited availability of testing services in certain settings. Additionally, reimbursement policies may lag behind technological advancements in point-of-care testing, leading to disparities in reimbursement rates for different types of tests and technologies.

  The lack of standardized reimbursement policies and coding systems for point-of-care infectious disease testing can complicate billing and reimbursement processes for healthcare providers, leading to administrative burdens and delays in reimbursement. In some cases, reimbursement rates may be tied to the volume of tests performed rather than the value or clinical utility of the testing service, creating incentives for overutilization and potentially compromising patient care.

  Addressing cost constraints and reimbursement issues requires collaboration among stakeholders, including policymakers, payers, healthcare providers, and industry partners. Efforts to establish standardized reimbursement policies, coding systems, and reimbursement rates for point-of-care infectious disease testing can help ensure equitable access to testing services and support sustainable adoption of these technologies. Additionally, initiatives to demonstrate the clinical and economic value of point-of-care testing through real-world evidence and outcomes data can inform reimbursement decisions and foster confidence among payers and healthcare providers.

Opportunity

• Expansion of Point-of-Care Testing into Emerging Markets
• Development of Multiplex Testing Platforms for Simultaneous Detection
• Integration of Artificial Intelligence for Automated Interpretation

• Partnerships and Collaborations for Product Development and Distribution - Partnerships and collaborations play a crucial role in driving innovation, accelerating product development, and expanding distribution channels in the Point-of-Care Infectious Disease Testing Market. Given the diverse and complex landscape of infectious diseases, collaboration among stakeholders—including healthcare providers, diagnostic companies, research institutions, and government agencies—is essential to address unmet needs, overcome technical challenges, and bring innovative testing solutions to market.

  Partnerships between diagnostic companies and research institutions enable the translation of cutting-edge research into commercially viable products. Collaborative research initiatives facilitate the development of novel diagnostic technologies, biomarkers, and testing algorithms, advancing the state-of-the-art in infectious disease testing. By leveraging complementary expertise and resources, partners can accelerate the pace of innovation and bring transformative technologies to market more efficiently.

  Partnerships between diagnostic companies and healthcare providers enable real-world validation and clinical implementation of new testing solutions. Collaborative studies and pilot programs conducted in partnership with healthcare providers allow diagnostic companies to demonstrate the clinical utility, performance, and economic value of their point-of-care testing devices in diverse patient populations and clinical settings. These partnerships also facilitate the integration of point-of-care testing into existing healthcare workflows, ensuring seamless adoption and utilization by frontline healthcare professionals.

  Partnerships between diagnostic companies and distributors enhance market access and expand distribution channels for point-of-care infectious disease testing products. Distributors play a critical role in reaching healthcare providers and end-users in diverse geographic regions, particularly in emerging markets and underserved areas. Collaborating with established distributors enables diagnostic companies to leverage existing networks, infrastructure, and market knowledge to effectively penetrate new markets and maximize market penetration.

Key players in Global Point Of Care Infectious Disease Testing Market include :

• Abbott
• Bio-Rad Laboratories, Inc
• Quest Diagnostics Inc
• Thermo Fisher Scientific, Inc
• Hoffmann-La Roche Ltd
• Danaher
• Siemens Healthineers
• Sight Diagnostics Ltd
• Cardinal Health
• Trinity Biotech

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis